Cardiologists Weigh Where the First Oral PCSK9 Pill Fits Now That the FDA Has Approved It

The Food and Drug Administration approved the first oral PCSK9 inhibitor on July 16, giving patients who need further LDL cholesterol reduction a daily pill option in a drug class that has been available only by injection. As liver cholesterol falls, the liver increases LDL receptors on its surface and clears more LDL from the blood. It is a protein that binds LDL receptors and marks them for degradation, so fewer receptors survive to clear LDL. In the pivotal trials, placebo-adjusted reductions were 55.8 percentage points in CORALreef Lipids and 59.4 percentage points in CORALreef HeFH. PCSK9 inhibitors preserve LDL receptors so the liver clears more LDL.